Tildrakizumab for Genital Psoriasis

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sun Pharmaceutical Industries Limited

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?Phase 3 study to evaluate the efficacy and safety of subcutaneous tildrakizumab in subjects with moderate to severe genital psoriasis.

Eligibility Criteria

This trial is for adults over 18 with moderate to severe genital psoriasis, often not well-managed by topical treatments. Participants should have less than 10% body surface area affected by non-genital plaque psoriasis and no active tuberculosis. They must understand the trial's risks, agree to follow its rules, and provide written consent.

Inclusion Criteria

Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines

I am 18 years old or older.

I have moderate to severe genital psoriasis.

+3 more

Exclusion Criteria

I don't have any health conditions that could make this study unsafe for me.

I am scheduled for surgery before the Week 16 check-up for a condition I had before treatment.

My psoriasis is not mainly plaque type but one of the other forms like erythrodermic or pustular.

+1 more

Participant Groups

The study tests Tildrakizumab's effectiveness and safety against a placebo in treating genital psoriasis. It's a phase 3 trial where participants receive either the actual drug or a placebo through subcutaneous injections.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tildrakizumab 100 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group2 Interventions